2021
Copy number aberration analysis to predict response to neoadjuvant anti-HER2 therapy: results from the NeoALTTO phase III clinical trial.
Venet D, Rediti M, Maetens M, Fumagalli D, Brown DN, Majjaj S, Salgado R, Pusztai L, Harbeck N, El-Abed S, Wang Y, Saura C, Gomez H, Semiglazov VF, de Azambuja E, Huober J, Nuciforo P, Di Cosimo S, Piccart M, Loi S, Rothé F, Sotiriou C. Copy number aberration analysis to predict response to neoadjuvant anti-HER2 therapy: results from the NeoALTTO phase III clinical trial. Clinical Cancer Research 2021, 27: clincanres.1317.2021. PMID: 34321278, DOI: 10.1158/1078-0432.ccr-21-1317.Peer-Reviewed Original ResearchConceptsPathologic complete responseNeoALTTO trialCopy number aberrationsBreast cancerHER2-positive early-stage breast cancerEstrogen receptor-positive subgroupNeoadjuvant anti-HER2 therapyEarly-stage breast cancerHER2-positive breast cancerPhase III clinical trialsAnti-HER2 therapyAnti-HER2 agentsPredictors of responseReceptor-positive subgroupNumber aberration analysisCopy number levelsWarrants further investigationHeterogeneity of responseComplete responseSurvival outcomesWhole cohortClinical trialsImmune processesPatientsSignificant association
2019
Quantitative MHC II protein expression levels in tumor epithelium to predict response to the PD1 inhibitor pembrolizumab in the I-SPY 2 Trial.
Wulfkuhle J, Yau C, Wolf D, Gallagher R, Brown Swigart L, Hirst G, Campbell M, Nanda R, Liu M, Pusztai L, Esserman L, Berry D, van 't Veer L, Petricoin E. Quantitative MHC II protein expression levels in tumor epithelium to predict response to the PD1 inhibitor pembrolizumab in the I-SPY 2 Trial. Journal Of Clinical Oncology 2019, 37: 2631-2631. DOI: 10.1200/jco.2019.37.15_suppl.2631.Peer-Reviewed Original ResearchI-SPY 2 TRIALImmune checkpoint inhibitorsCheckpoint inhibitorsTumor epitheliumPD1 inhibitor pembrolizumabTumor antigen presentationHER2-negative subtypeMHC-II expressionTumor cell expressionPredictors of responseWilcoxon rank sum testPositive associationRank sum testProtein expression levelsImmune activationControl armAntigen presentationResponse predictorsHR subgroupsB cellsCell expressionPatientsSum testProtein expressionTumors
2011
A Genomic Predictor of Response and Survival Following Taxane-Anthracycline Chemotherapy for Invasive Breast Cancer
Hatzis C, Pusztai L, Valero V, Booser DJ, Esserman L, Lluch A, Vidaurre T, Holmes F, Souchon E, Wang H, Martin M, Cotrina J, Gomez H, Hubbard R, Chacón JI, Ferrer-Lozano J, Dyer R, Buxton M, Gong Y, Wu Y, Ibrahim N, Andreopoulou E, Ueno NT, Hunt K, Yang W, Nazario A, DeMichele A, O’Shaughnessy J, Hortobagyi GN, Symmans WF. A Genomic Predictor of Response and Survival Following Taxane-Anthracycline Chemotherapy for Invasive Breast Cancer. JAMA 2011, 305: 1873-1881. PMID: 21558518, PMCID: PMC5638042, DOI: 10.1001/jama.2011.593.Peer-Reviewed Original ResearchMeSH KeywordsAdultAlgorithmsAnthracyclinesAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBiopsy, NeedleBreast NeoplasmsBridged-Ring CompoundsDisease-Free SurvivalDrug Resistance, NeoplasmFemaleForecastingGene Expression ProfilingGenes, erbB-2Genes, NeoplasmGenomicsHumansMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalOligonucleotide Array Sequence AnalysisPredictive Value of TestsPrognosisProspective StudiesReceptors, EstrogenRiskTaxoidsConceptsDistant relapse-free survivalInvasive breast cancerBreast cancerGenomic predictorsD. Anderson Cancer CenterAnthracycline-based regimensER-negative subsetExcellent pathologic responseProspective multicenter studyRelapse-free survivalAbsolute risk reductionStandard cancer treatmentPredictors of responseIndependent validation cohortAnderson Cancer CenterNegative breast cancerCancer treatment strategiesSequential taxaneNeoadjuvant chemotherapyPreoperative chemotherapyPathologic responseWorse survivalEndocrine sensitivityER statusMulticenter study
2010
Predictors of Tumor Progression During Neoadjuvant Chemotherapy in Breast Cancer
Caudle AS, Gonzalez-Angulo AM, Hunt KK, Liu P, Pusztai L, Symmans WF, Kuerer HM, Mittendorf EA, Hortobagyi GN, Meric-Bernstam F. Predictors of Tumor Progression During Neoadjuvant Chemotherapy in Breast Cancer. Journal Of Clinical Oncology 2010, 28: 1821-1828. PMID: 20231683, PMCID: PMC2860366, DOI: 10.1200/jco.2009.25.3286.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAnthracyclinesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsBridged-Ring CompoundsCarcinoma, Ductal, BreastCarcinoma, LobularChemotherapy, AdjuvantDisease ProgressionFemaleHumansMiddle AgedNeoadjuvant TherapyReceptors, EstrogenReceptors, ProgesteroneSurvival RateTaxoidsTreatment OutcomeYoung AdultConceptsHigh Ki-67 scoreNeoadjuvant chemotherapyKi-67 scoreStable diseaseBreast cancerEstrogen receptorMultivariate analysisDistant disease-free survivalER/PR negativityFirst-line surgical approachTumor progressionMost breast cancer patientsDisease-free survivalStandard neoadjuvant chemotherapyCancer clinical stageAmerican Joint CommitteeBreast cancer patientsAfrican American raceAdvanced tumor stagePredictors of responseHigh nuclear gradeHigh tumor gradeNegative estrogen receptorNovel molecular predictorsPR negativityAssessment of an RNA interference screen-derived mitotic and ceramide pathway metagene as a predictor of response to neoadjuvant paclitaxel for primary triple-negative breast cancer: a retrospective analysis of five clinical trials
Juul N, Szallasi Z, Eklund AC, Li Q, Burrell RA, Gerlinger M, Valero V, Andreopoulou E, Esteva FJ, Symmans WF, Desmedt C, Haibe-Kains B, Sotiriou C, Pusztai L, Swanton C. Assessment of an RNA interference screen-derived mitotic and ceramide pathway metagene as a predictor of response to neoadjuvant paclitaxel for primary triple-negative breast cancer: a retrospective analysis of five clinical trials. The Lancet Oncology 2010, 11: 358-365. PMID: 20189874, DOI: 10.1016/s1470-2045(10)70018-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsArea Under CurveBreast NeoplasmsCeramidesDrug Screening Assays, AntitumorFemaleHumansLogistic ModelsMetagenomicsMiddle AgedMitosisModels, GeneticMultivariate AnalysisNeoadjuvant TherapyPaclitaxelPredictive Value of TestsRetrospective StudiesRNA InterferenceConceptsTriple-negative breast cancerPathological complete responseMultivariate logistic regressionBreast cancerClinical trialsPrimary triple-negative breast cancerEpidermal growth factor receptor 2Logistic regressionBreast Cancer Research FoundationAddition of taxanesPaclitaxel-containing chemotherapyClinical trial cohortProportion of patientsCohort of patientsGrowth factor receptor 2Paclitaxel combination chemotherapyUK Medical Research CouncilAlternative treatment regimensPredictors of responseCancer Research UKBreast cancer cell linesTriple-negative breast cancer cell linesFactor receptor 2Cancer Research FoundationCell lines
2008
Research Issues Affecting Preoperative Systemic Therapy for Operable Breast Cancer
Wolff AC, Berry D, Carey LA, Colleoni M, Dowsett M, Ellis M, Garber JE, Mankoff D, Paik S, Pusztai L, Smith ML, Zujewski J. Research Issues Affecting Preoperative Systemic Therapy for Operable Breast Cancer. Journal Of Clinical Oncology 2008, 26: 806-813. PMID: 18258990, DOI: 10.1200/jco.2007.15.2983.Peer-Reviewed Original ResearchMeSH KeywordsAngiogenesis InhibitorsAntineoplastic AgentsApoptosisBiomarkersBiomedical ResearchBreast NeoplasmsCell ProliferationEpidemiologic Research DesignErbB ReceptorsEthics, ClinicalFemaleGene Expression ProfilingHumansMastectomy, SegmentalNeoadjuvant TherapyPatient AdvocacyPreoperative CarePrognosisReceptors, SteroidTreatment OutcomeConceptsPreoperative systemic therapyOperable breast cancerSystemic therapyBreast cancerTrial designEnd pointCohesive multidisciplinary teamBreast conservation ratesEffective alternative therapyTrial end pointsLong-term outcomesSpecific breast cancer subtypesPredictors of responseNovel trial designsIntermediate end pointsBreast cancer subtypesIndividual patient subgroupsAdjuvant trialsPatient subgroupsSmall trialsAlternative therapiesMAIN OUTCOMEClinical careCancer subtypesMultidisciplinary team
2007
Pharmacogenomic Predictor Discovery in Phase II Clinical Trials for Breast Cancer
Pusztai L, Anderson K, Hess KR. Pharmacogenomic Predictor Discovery in Phase II Clinical Trials for Breast Cancer. Clinical Cancer Research 2007, 13: 6080-6086. PMID: 17947471, DOI: 10.1158/1078-0432.ccr-07-0809.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials, Phase II as TopicGene Expression ProfilingGene Expression Regulation, NeoplasticHumansIn Situ Hybridization, FluorescenceOligonucleotide Array Sequence AnalysisPharmacogeneticsProbabilityRNA, MessengerTissue DistributionTrastuzumabConceptsPhase II studyPhase II trialII trialII studyBreast cancerTwo-stage phase II trialPhase II clinical trialPhase II trial designPredictors of responseMarker-positive patientsPhase II designUnselected patientsPatient populationClinical trialsTrastuzumab responseInsufficient responseTrial designResponse markersSame drugResponse rateMarker testingPotential predictorsMarker assessmentTrialsPatients
2003
HER-2/neu testing in breast cancer.
Ross JS, Fletcher JA, Bloom KJ, Linette GP, Stec J, Clark E, Ayers M, Symmans WF, Pusztai L, Hortobagyi GN. HER-2/neu testing in breast cancer. American Journal Of Clinical Pathology 2003, 120 Suppl: s53-71. PMID: 15298144, DOI: 10.1309/949fpq1aq3p0rlc0.Peer-Reviewed Original ResearchConceptsBreast cancerNeu testingNeu statusProspective clinical outcome studyTrastuzumab-based therapyMajor clinical trialsEarly clinical stagePredictors of responseClinical outcome studiesBreast cancer specimensAdvanced diseaseClinical responseClinical stageClinical trialsStandards of practiceCancer specimensImmunohistochemical analysisOutcome studiesPotential efficacyCancerSitu hybridization techniqueRecent evidenceTherapySitu hybridization methodExcellent results